You should not be given OPDIVO
if you are allergic (hypersensitive) to nivolumab or any of the other ingredients of OPDIVO. If you are not sure, talk to your doctor.
Check with your doctor or nurse before you are given OPDIVO if:
you have an autoimmune disease (a condition where the body attacks its own cells) like Crohn's, ulcerative colitis or lupus;
you have any history of inflammation of the lungs
you have been told your cancer has spread to your brain
you have melanoma of the eye
you were previously given ipilimumab (YERVOY®), another medicine for the treatment of advanced melanoma, and experienced side effects because of this medicine.
you are taking any medicines that suppress your immune system, such as corticosteroids, since these medicines may interfere with the effect of OPDIVO. However, once you are treated with OPDIVO, your doctor may give you corticosteroids to reduce any possible side effects that you may have during your treatment and this will not impact the effect of the medicine.
OPDIVO may cause:
Problems with your lungs such as breathing difficulties, or cough. These may be signs of inflammation of the lungs (pneumonitis or interstitial lung disease).
Diarrhoea (watery, loose or soft stools) or any symptoms of inflammation of the intestines (colitis), such as stomach pain and mucus or blood in the stool.
Inflammation of the liver (hepatitis). Signs and symptoms of hepatitis may include abnormal liver function tests, eye or skin yellowing (jaundice), pain on the right side of your stomach area, or tiredness.
Inflammation or problems with your kidneys. Signs and symptoms may include abnormal kidney function tests decreased volume of urine, and kidney failure.
Problems with your hormone producing glands (including the thyroid, pituitary, and adrenal glands) that may affect how these glands work. Signs and symptoms that your glands are not working properly may include fatigue (extreme tiredness), weight change or headache and visual disturbances.
Diabetes (symptoms include excessive thirst, the passing of a greatly increased amount of urine, increase in appetite with a loss of weight, feeling tired, drowsy, weak, depressed, irritable and generally unwell) or diabetic ketoacidosis (acid in the blood produced from diabetes).
Inflammation of the skin that can lead to rash and itching. Severe and possibly fatal peeling of the skin (toxic epidermal necrolysis, Steven-Johnson syndrome).
Loss of the covering around the nerves (demyelination), inflammation of the nerves caused by the body attacking itself, causing numbness, weakness, tingling or burning pain.
A condition in which the muscles become weak and tire easily (myasthenic syndrome).
A temporary inflammation of the nerves that causes pain, weakness and paralysis in the extremities (Guillain-Barré syndrome).
Inflammation of the brain
Inflammation of muscles causing pain or stiffness
Inflammation of the heart (myocarditis) characterised by shortness of breath, fatigue, palpitations or chest pain
Muscle breakdown/injury (rhabdomyolysis) characterised by muscle pain, weakness, nausea or vomiting.
Solid organ transplant rejection.
Tell your doctor immediately if you have any signs or symptoms of the possible side effects listed above or if your symptoms get worse.
Do not try to treat your symptoms with other medicines.
Complications of stem cell transplant that uses donor cells (allogeneic) may occur after treatment with Opdivo.
These complications can be severe and can lead to death. Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant.
POSSIBLE SIDE EFFECTS
Like all medicines, OPDIVO can cause side effects, although not everybody gets them. Your doctor will discuss these with you and will explain the risks and benefits of your treatment.
Do not try to treat your symptoms with other medicines.
Do not be alarmed by possible side effects.
You may not experience any of them.
Ask your doctor to answer any questions you may have.
The following side effects have been reported in clinical trials when OPDIVO has been given alone:
Very common (may affect more than 1 in 10 people)
Decrease in some white blood cells
Diarrhoea (watery, loose or soft stools), nausea
Skin rash sometimes with blisters, itching
Feeling tired or weak
Common (may affect up to 1 in 10 people)
Infections of the upper respiratory tract
Underactive thyroid gland, which can cause tiredness or weight gain, overactive thyroid gland, which can cause rapid heart rate, sweating and weight loss
Decreased appetite
Inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs, headaches, dizziness
Inflammation of the lungs (pneumonitis), characterised by coughing and difficulty breathing
coughing, shortness of breath (dyspnoea)
Inflammation of the intestines (colitis)
Stomach pain, constipation
Mouth ulcers and cold sores (stomatitis), vomiting, dry mouth
Skin colour changes in patches (vitiligo), dry skin, redness of the skin, hair loss or thinning
Pain in the muscles, bones and joints
Fever, oedema (swelling)
Allergic reaction, reaction related to the infusion of the medicine
High blood pressure (hypertension)
Uncommon (may affect up to 1 in 100 people)
Serious lung infection (pneumonia), bronchitis
Decreased secretion of hormones produced by adrenal glands (glands situated above the kidneys), underactive function (hypopituitarism) or inflammation (hypophysitis) of the pituitary gland situated at the base of the brain, swelling of the thyroid gland, diabetes
Inflammation of the pancreas, inflammation of the stomach (gastritis)
Dehydration
Increased acid level in the blood
Increase in some white blood cells
Inflammation of the eye, which causes pain and redness, blurred vision, dry eyes
Inflammation in the kidney, kidney failure
Fast heart rate
Arthritis
Damage to nerves causing numbness and weakness (polyneuropathy),inflammation of the nerves caused by the body attacking itself, causing numbness, weakness, tingling and burning pain
Inflammation of the liver (hepatitis)
Fluid around the lungs
Severe condition of the skin that causes red, often itchy spots, similar to rash of measles, which starts on the limbs and sometimes on the face and the rest of the body (erythema multiforme), skin disease with thickened patches of red skin, often silvery scales (psoriasis), skin conditions of the face where the nose and cheeks are unusually red (rosacea), hives (itchy, bumpy rash)
Pain, chest pain
Rare (may affect up to 1 in 1000 people)
Life threatening allergic reaction
Severe and possibly fatal peeling of the skin (toxic epidermal necrolysis, Steven-Johnson syndrome)
Loss of the covering around the nerves (demyelination) pain
A condition in which the muscles become weak and tire easily (myasthenic syndrome)
A temporary inflammation of the nerves that causes pain, weakness and paralysis in the extremities (Guillain-Barré syndrome)
Inflammation of the brain
Ulcer of the small intestine
Blockage of the bile ducts
Fluid in lungs
Acid in the blood produced from diabetes (diabetic ketoacidosis)
A disease causing inflammation or enlargement of a lymph node (Kikuchi lymphadenitis)
Changes in the rhythm or rate of the heart, abnormal heart rhythm
Inflammation of the heart (myocarditis) characterised by shortness of breath, fatigue, palpitations or chest pain
Inflammation of muscles causing pain or stiffness
Muscle breakdown/injury (rhabdomyolysis) characterised by muscle pain, weakness, nausea or vomiting.
Myopathy (aching muscles, muscle tenderness or weakness, not caused by exercise)
Inflammatory disease of blood vessels
Disease in which the
immune system attacks the glands that make moisture for the body, such as tears and
saliva (Sjogren's syndrome)
Changes in test results
OPDIVO may cause changes in the results of tests carried out by your doctor. These include:
Abnormal liver function tests
Abnormal kidney function tests
A decreased number of red blood cells (which carry oxygen), white blood cells (which are important in fighting infection) or platelets (cells which help the blood clot)
Abnormal levels of calcium, potassium, magnesium or sodium in your blood
Decrease in body weight
Higher levels of sugar in your blood (hyperglycaemia)
The following side effects have been reported in clinical trials when OPDIVO has been given in combination with YERVOY:
Very common (may affect more than 1 in 10 people)
Overactive thyroid gland, which can cause rapid heart rate, sweating and weight loss
Underactive thyroid gland, which can cause tiredness or weight gain
Decreased appetite
Headache
Shortness of breath (dyspnoea)
Inflammation of the intestines (colitis), diarrhoea (watery, loose or soft stools), vomiting, nausea, stomach pain
Skin rash sometimes with blisters, itching
Pain in the joints, muscles and bones
Feeling tired or weak
Fever
Common (may affect up to 1 in 10 people)
Serious lung infection (pneumonia), infections of the upper respiratory tract
Increase in some white blood cells
Decreased secretion of hormones produced by adrenal glands (glands situated above the kidneys); underactive function (hypopituitarism) or inflammation (hypophysitis) of the pituitary gland situated at the base of the brain; overactive thyroid gland, which can cause rapid heart rate, sweating and weight loss; inflammation of the thyroid gland (hyperthyroidism); swelling of the thyroid gland
Dehydration
Inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs; dizziness
Inflammation of the eye, which causes pain and redness, blurred vision
Fast heart rate
High blood pressure (hypertension)
Inflammation of the lungs (pneumonitis), characterised by coughing and difficulty breathing, blood clots, cough
Mouth ulcers and cold sores (stomatitis), inflammation of the pancreas (pancreatitis), constipation, dry mouth
Inflammation of the liver
Skin colour change in patches (vitiligo), dry skin, redness of the skin, unusual hair loss or thinning, hives (itchy rash)
Pain in the muscles and bones
Kidney failure (including abrupt loss of kidney function)
Oedema (swelling), pain
Allergic reaction, reactions related to the infusion of the medicine
Uncommon (may affect up to 1 in 100 people)
Inflammation of the brain
Bronchitis
Chronic diseases associated with a build-up of inflammatory cells in various organs and tissues, most commonly the lungs (sarcoidosis)
Acid in the blood produced from diabetes (diabetic ketoacidosis), diabetes
A temporary inflammation of the nerves that causes pain, weakness and paralysis in the extremities (Guillain-Barré syndrome); damage to nerves causing numbness and weakness (polyneuropathy); inflammation of the nerves; foot drop (peroneal nerve palsy); inflammation of the nerves caused by the body attacking itself, causing numbness, weakness, tingling or burning pain (autoimmune neuropathy)
Changes in the rhythm or rate of the heart beat, abnormal heart rhythm
Fluid around the lungs
Intestinal perforation, inflammation of the stomach (gastritis), inflammation of the duodenum (duodenitis)
Skin disease with thickened patches of red skin, often with silvery scales (psoriasis)
Chronic disease of joints (spondyloarthropathy)
Disease in which the
immune system attacks the glands that make moisture for the body, such as tears and
saliva (Sjogren's syndrome)
Inflammation of the joints (arthritis)
Inflammation of muscles (myositis) causing pain or stiffness
Inflammation of the kidney (nephritis)
Chest pain
Inflammation of the heart (myocarditis) characterised by shortness of breath, fatigue, palpitations or chest pain.
Muscle breakdown/injury (rhabdomyolysis) characterised by muscle pain, weakness, nausea or vomiting.
Rare (may affect up to 1 in 1000 people)
Severe and possibly fatal peeling of the skin (toxic epidermal necrolysis, Steven-Johnson syndrome)
Changes in test results
OPDIVO in combination with YERVOY may cause changes in the results of tests carried out by your doctor. These include:
Abnormal liver function tests
Abnormal kidney function tests
A decreased number of red blood cells (which carry oxygen), white blood cells (which are important in fighting infection) or platelets (cells which help the blood to clot)
An increased level of the enzyme that breaks down fats and of the enzyme that breaks down starch.
Abnormal levels of calcium, potassium, magnesium or sodium in your blood
Higher blood levels of bilirubin
Decrease in body weight
Higher (hyperglycaemia) or lower (hypoglycaemia) levels of sugar in your blood
